Five-year mean follow-up of NeoHexa sirolimus eluting coronary stent: A retrospective evaluation of long-term safety and efficacy

BACKGROUND: Patients suffering from coronary artery disease (CAD) are experiencing significantly improved outcomes in clinical practice through the use of drug-eluting stents. However, there is still a dearth of real-world long-term data, especially from different patient populations in India, whose clinical presentation is frequently different from trial patient populations. The purpose of this study was to retrospectively assess NeoHexa coronary stent's long-term safety and effectiveness in all-comer patients, covering both ordinary and pandemic-era clinical settings, during an average follow-up duration of five years. AIM: To investigate long-term safety and effectiveness of NeoHexa sirolimus-eluting stent (SES) in managing CAD among real-world all-comer patient population. METHODS: 740 individuals with CAD who had undergone percutaneous coronary intervention with NeoHexa SES minimum 2 years prior to the study were included in this single center retrospective, observational analysis. The data was extracted from medical records and patients were followed-up telephonically. The primary safety endpoint included cumulative major adverse cardiac event (MACE) at time of follow up (≥ 2 years after implantation). MACE was defined as a composite endpoint consisting of cardiac death, myocardial infarction, and target lesion revascularization (TLR). The primary efficacy endpoint involved sustained relief of angina or angina-equivalent symptoms at two years post- implantation, without the need for TLR. The secondary endpoints included individual components of MACE, all-cause mortality, target vessel revascularization and stent thrombosis. RESULTS: At a mean follow-up period of 62.17 ± 9.86 months, 32 subjects (4.32%) experienced the key safety endpoint of MACE. This included 13 patients (1.76%) with TLR/target vessel revascularization and 19 patients (2.57%) with cardiac mortality. Additionally, non-cardiac mortality occurred in 35 cases (4.73%). In terms of effectiveness, 673 patients (90.95%) did not require revascularization and remained clinically stable in New York Heart Association functional class I-II. CONCLUSION: The study suggests favourable long-term safety and efficacy of NeoHexa SES in a real-world setting with varied clinical presentations.